Federal regulators have expanded the approved use of Minnesota-based devicemaker Medtronic's CoreValve transcatheter aortic valve replacement system for patients with failing artificial heart valves and are at high risk of complications from undergoing traditional surgery.
The U.S. Food and Drug Administration announced Monday it was, for the first time, allowing the maker of a TAVR device to market the product for use in “valve-in-valve” aortic replacement, replacement of an artificial valve that was previously implanted though surgery.
The FDA's expanded use approval has major implications for more widespread use of TAVR, said Dr. Stephen Ramee, medical director for structural and valvular heart disease programs at Ochsner Medical Center in New Orleans.
The announcement marks an important advance toward the preferred use of bioprosthetic tissue valves over mechanical valves, which require a patient to take blood-thinning medications for the rest of their life, he said.
“I think this is a game-changer, not so much for transcatheter valves, but for surgical valve replacement,” Ramee said. “If you can replace a tissue valve and not require a patient to be on anticoagulation their entire life, I think the tissue valves are going to be the preferred method of treatment of aortic stenosis going forward.”
But despite the system's promise, financial concerns over the cost of TAVR treatment could hinder its widespread use. The devices can run more than $30,000 compared with the $4,000 to $7,000 price of surgical valves.
“The cost and reimbursements issues need to be brought into alliance so that we don't have disincentives,” said Dr. Spencer King, editor-in-chief of the Journal of the American College of Cardiology: Cardiovascular Interventions.
Reimbursement for performing TAVR procedures is an issue that has to be addressed for patients to gain greater access to the treatment, King said.
“The CoreValve System offers a less invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William Maisel, deputy center director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a statement.
“The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology,” he said.
FDA approval was based on a review of clinical trial data collected among 143 patients where it was found the estimated rate of patient survival without incurring a major stroke was 95% after 30 days and 89% after six months.
TAVR was first approved by the FDA in 2011 for use in patients whose health conditions made them ineligible for traditional open-heart surgery. The procedure involves insertion of a prosthetic valve with a catheter that is threaded through an artery via the groin or rib cage. In 2012, an expanded use of TAVR was approved for patients at “high-risk” for surgery.
Valve replacement is most commonly performed for the treatment of aortic stenosis, a narrowing of the heart's aortic valve. Recently released results of trials looking at the five-year outcomes of patients who underwent TAVR procedures found they had similar risks of mortality to those who received aortic valves through surgery.